Novo Nordisk A/S

Welcome to this Novo Nordisk call regarding our earnings for the first nine months of 2021 and outlook for the year. This call follows the early announcement of the high-level results and race guidance published on Friday last week. I'm Lars Rurgard Jorgensen, the CEO of Novo Nordisk. With me today I have Chief Financial Officer Carsten von Knusen, Executive Vice President and Head of Commercial Strategy and Corporate Affairs Camille Sylvestre, Executive Vice President and Head of North America Operations, Doug Lange. And finally, Executive Vice President and Head of Development, Martin Holst Lange. All presenters will be available for the Q&A session. Today's earnings release and the slides for this call are made available on our website, noahnordish.com. Please note that this call is being webcasted live and a recording will be made available on NOAH North's website. The call is scheduled to last for one hour. Please turn to the next slide. The presentation is structured as outlined on slide two. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified. The Q&A session will begin in about 25 minutes. Please turn to slide three. As always, I need to advise you that this conference call will contain forward-looking statements. Such forward-looking statements are subject to risk and uncertainty that could cause actual results to differ materially from expectations. For further information on the risk factors, including the uncertainties around COVID-19, please see the company announcement for the first nine months of 2021 and the slide prepared for this presentation. Please turn to the next slide. In the first nine months of 2021, NorNoisk has progressed on all four dimensions of our strategic aspirations. I would like to highlight a few today. Within purpose and sustainability, we have expanded the Changing Diabetes in Children program. It now includes three additional countries, Indonesia, Pakistan, and Peru, to reach a total of 18 countries included in the program. This will support our aspiration of reaching 100,000 children and young people living with type 1 diabetes in low-resource settings by 2030. Today, the program is providing free care to 30,000 children, adolescents in low- and middle-income countries. Within our Circular for Zero strategy, we are excited that NorNoisk has received an award at the Climate Week in New York City. The award was given for our work in accelerating the global transition to 100% renewable energy. Martin will come back to key milestones within R&D, but I would like to briefly share my perspectives. With the initiation of two Phase III programs within obesity and other serious chronic diseases, we now have ongoing late-stage clinical trials within all of our therapy areas. The Phase III initiation with Siltivacumab demonstrated our ability to successfully integrate the late-stage assets we acquired from Covetia Therapeutics in 2020 into our internal clinical development programs. For commercial execution, we have progressed on all three strategic aspirations. Specifically for obesity care, the initial U.S. demand for Vigovi has significantly exceeded our expectations and underscored the high unmet need for people living with obesity. Camilla and Doug will elaborate further on obesity and provide details on our other therapeutic areas later. Lastly, leaving financials to Carson, we are pleased with the sales growth of 13% and operating profit growth of 12% in the first nine months of 2021, both measured in constant exchange rates. With that, I'll give the word to Camille for an update on commercial execution.

Thank you, Lars, and please turn to slide 5. In the first nine months of 2021, our total sales increased by 13%. The sales increase was driven by both operating units with international operations growing 13% and North America operations also growing by 13%. GLP-1 sales increased 30%, driven by North America growing 24% and international operations growing 47%. Insulin sales increased by 2%, driven by 6% growth in international operations, partially offset by an 8% sales decline in North America operations. The U.S. insulin sales declined by 9%, driven by a decline in volume and realized prices, the latter driven by channel and payer mix, as well as rebate enhancements. Obesity care sales grew 49% overall. In international operations, Saxenda sales grew 51%, and in North America operations, obesity care sales grew 48%. In the U.S., obesity care sales grew 49%, driven by both Saxenda and Vigovii. Biofarm sales increased by 4%, driven by North America operations growing 6%, and international operations growing by 3%. Please turn to slide 6. In line with our strategic aspiration of reaching one-third of the diabetes value market by 2025, our sales growth of 13% is faster than the overall diabetes market, and hence we have improved our market share by 0.7 percentage points, to 29.9%. This increase reflects GLP-1 growth of 30% and market share gains in both operating units. Currently, USMPIC has been launched in 67 countries and Rebelsus in 23 countries. Please turn to slide seven. In international operations, diabetes care sales increased by 14% in the first nine months of 2021, driven by all geographies and therapy areas. GLP-1 sales increased by 47% in the first nine months of 2021. Novo Nordisk remains the market leader in international operations with a GLP-1 market share of 57.5%, reflecting an increase of 4.7 percentage points compared to one year ago. This is driven by share gains across geographies and overall GLP-1 share of growth in international operations of 73.6%. Please turn to the next slide. BioPharm sales grew by 4% in the first nine months of 2021. This was driven by 6% sales growth in North America operations and 3% sales growth in international operations. Rare blood disorders grew by 7%, driven by uptake of our launch products, Espirop and Refixia, as well as Novo7 and Novo8. Specifically, hemophilia A products grew by 23%, hemophilia B sales by 26%, and NOVA7 by 2%. Where endocrine disorder sales were flat, the unchanged sales reflect international operations increasing by 6%, offset by North America operations decreasing by 10%. And now to Doc for an update on US GLP-1 and obesity care.

Thank you, Camilla. Please turn to the next slide. The U.S. GLP-1 volume market growth is around 30%, comparing Q3 of 2021 to Q3 of 2020, driven by once-weekly injectable GLP-1s as well as Rebelsys. Novo Nordisk's new-to-brand market share leadership is now 63.7%, driven by continued uptake of Ozempic and Rebelsys. Additionally, Ozempic remains the NBRX market share leader within the injectable GLP-1s and, measured on total scripts, Novo Nordisk remains the market leader with more than 50 percent market share. Please turn to the next slide. In the U.S., Rebelsys' total prescription trajectory continues to steadily increase, now above 40,000 prescriptions per week. Since mid-May, our sales force has been fully back out in the field, and Rebelsys was the second largest contributor to growth for Novo Nordisk in the first nine months of 2021. And if you look at the U.S. specifically, Rebelsys accounted for 36 percent of the growth in the first nine months of 2021. Furthermore, leading indicators such as prescriber breadth, HCP awareness, and sourcing from outside the GLP-1 class remain encouraging. Importantly, we are confident in the product and its long-term potential. Don't forget that within the Pioneer Program, Rebelsys demonstrated itself as the most efficacious OAD on the market as measured on A1C and weight. Now, outside of the U.S., Rebelsys now has been launched in 22 countries, with one key market being Japan, where Rebelsys has reached a 0.9% modern OAD value market share. While underlying parameters are on track, it should still be noted that Japan was in a third COVID-19 lockdown until the end of September, which has made it difficult for patients and sales forces alike to reach doctors. Please go to the next slide. Globally, obesity care sales increased by 49% with 48% growth in North American operations and 51% in international operations. As Lars mentioned earlier, the U.S. launch of Ogovi has significantly exceeded our expectations, underlying the high met needs for people with obesity. This has put the supply chain under pressure. and patients may temporarily experience a delay in getting prescriptions filled throughout 2021. We continue gradual increase in supply and expect to be able to meet demand in early 2022, of course, depending upon demand. The initial feedback from patients and prescribers continues to be encouraging. Nineteen weeks after launch, Wegovy has already surpassed 670 weekly script levels, reaching around 17,000 scripts per week. More than 70% of Wolgovy prescriptions are new to the anti-obesity medication class. Thereby, Wolgovy is expanding the branded anti-obesity market. Market access has progressed since launch, and three national payers have now unblocked Wolgovy from their national formulary. We are excited to share that commercial formulary access is now around 60% for Wolgovy, compared to around 80% for Saxenda. Outside the U.S., Wagovi has been submitted for regulatory review in Japan, and we expect a decision from EU authorities before year's end. Now over to you, Martin, for an update on R&D.